BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 15950345 · Received December 9, 2022

    Report

    Report Number
    1314492-2022-05305
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H3, H6 AND H10: THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS THAT IS POTENTIALLY ASSOCIATED WITH THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP TOOK "TWICE AS LONG TO INFUSE" DURING CHEMOTHERAPY IN THE ONCOLOGY UNIT. THE LOG WAS REVIEWED AND THERE WERE MULTIPLE ALARMS FOR UPSTREAM OCCLUSION, DOWNSTREAM OCCLUSION, AND AIR IN LINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2916609 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CHEMOTHERAPY